What’s our best chance of ensuring chemical safety?

Richard Denison, Ph.D.is a Lead Senior Scientist.

The 1976 Toxic Substances Control Act (TSCA) created the serious problem we face today when it grandfathered in all chemicals in use at the time without requiring any safety testing or reviews.  Nearly 40 years on, we have a daunting task ahead of us to establish a new system that is accountable for the safety of chemicals.  It is essential that we get started as soon as possible.

The Lautenberg Act, which would require safety reviews of all chemicals in commerce, represents a fundamental change in our country’s chemicals policy:  it turns us away from the passive system under current law that simply assumes chemicals are safe and toward an active system that requires evidence of safety for chemicals to get or stay on the market.  It’s a huge paradigm shift, which won’t happen overnight, but is likely to have far-reaching consequences.  

But is the pace of the program fast enough?

Under the Lautenberg Act, EPA can transition to the new system by using its existing resources to continue ongoing assessments and begin evaluating additional chemicals, and then increase its pace over time.  EPA is required to immediately identify and start assessing a minimum of 10 “high priority” chemicals even before the prioritization process is established.  As procedures are put in place and user fees begin to flow into EPA’s coffers (each of which must be established through new rules), the number of high-priority chemicals undergoing assessments must be raised, to a minimum of 20 chemicals by three years after enactment and a minimum of 25 chemicals by five years.

Once EPA has designated a chemical as high-priority, a safety assessment and safety determination must be completed within three years.  If EPA finds the chemical does not meet the safety standard, risk management measures must be imposed by rule within two more years.  EPA is permitted to extend these deadlines – which are judicially enforceable – for an aggregate period not to exceed two years, upon showing of cause.

These numbers have been criticized by some stakeholders as too small and too slow.  Ensuring higher numbers and faster timelines would of course be desirable, and there may be additional changes that can be made to the bill to speed up the process.  But there are real, practical reasons not to mandate too much, too fast.  Requiring the agency to quickly review large numbers of chemicals with overly-stringent deadlines could, for example, force EPA to:  (1) miss deadlines and quotas from the outset, setting the program up for failure; (2) choose “easy” chemicals it can do faster instead of those most needing assessment; and/or (3) do a poor job on assessments.  None of these outcomes is in anyone’s interest.

A recent report from the Bureau of National Affairs’ Daily Environment Report points out some of the challenges EPA will face in implementing a new TSCA, including identifying and hiring additional staff with the specialized skills needed to assess the safety of chemicals and develop regulations – a process that will take some time.

EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, Jim Jones, in recent testimony before the Senate Environment and Public Works Committee said there were limits to the number of chemicals the agency could handle even with greatly expanded resources:

[E]ven in the pesticides program, where we have about three times as many resources under the Food Quality Protection Act, the most output we were ultimately able to do is in the range of about 40 [chemical assessments] a year.  Based on that experience, I would expect that would probably be true in the TSCA sense as well.

It is essential to realize, however, that right now under TSCA, EPA has no mandate to review any existing chemicals, and it is reviewing few and acting on virtually none.  That state of affairs will continue until we get a new law.

Can we just leave it to the states?

In the absence of TSCA reform, the alternative is a continued reliance on state-by-state actions.  Those actions have been vital both in reducing some uses of some of the most problematic chemicals in use today and in driving the chemical industry to support TSCA reform.

But while some states have worked very hard to fill the void left by the broken federal system, their actions leave many chemicals unaddressed and many Americans without protection.  Although about 200 actions addressing chemicals in products have been taken by more than 30 states in the decades since TSCA passed in 1976, those actions have restricted only about a dozen chemicals or chemical categories, and only select uses of those substances.  And most of those states have enacted only one or two restrictions.  Small states like Nevada and New Mexico do not have the resources to implement chemical programs.  Many larger states have limited political willpower to take on these issues.  Except for a ban in brake pads enacted by California and Washington, no state has acted to ban the production or use of asbestos, a chemical at the center of the debate over TSCA reform.

Some of those state actions have had national impact, for example, by leading companies to reformulate products that they sell nationally.  Interestingly, some state actions have had broader impact on a chemical’s use not through direct restrictions, but rather by flagging it as a chemical of concern or requiring reporting or disclosure of its use.  Those types of actions by states would be able to continue unabated under the Lautenberg Act.  California’s Proposition 65 warning label requirements have also spurred companies to move away from use of problematic chemicals, sometimes on a national and even international basis.  The Lautenberg Act explicitly preserves Proposition 65, including both past and future listings of chemicals subject to its warning and labeling requirements.

Perhaps the most common of the state actions – restricting the use of bisphenol A (BPA) in baby bottles and sippy cups – has clearly had national impact, but the market response to such bans has too often been to replace BPA with a closely related chemical that may be just as problematic.  It should also be noted that these actions on BPA address a use that falls outside the scope of TSCA (it is regulated by FDA, not EPA), and hence they would not be preempted under the Lautenberg Act.

What about California’s Green Chemistry Initiative?

The job of assessing and regulating chemical safety is not easy, takes time, and can be highly charged because of what is at stake both for public health and the environment and affected companies that make or use chemicals.  Some argue that action to restrict chemicals is inherently easier and faster at the state level than in Washington, DC.  While that may be the case for some types of actions, such as legislative bans of individual chemicals for specific uses, California’s experience in implementing its signature Green Chemistry Initiative and associated Safer Consumer Products (SCP) regulations is illustrative of the challenges and limitations that even those states with the most resources face in this arena, especially in trying to implement a more systematic approach.

The law that authorized the SCP regulations was passed by the California legislature in 2008.  The SCP regulations, which established the Safer Consumer Products Program, took effect five years later, in October 2013.  Much of the reason it took so long was the heavy lobbying by stakeholders on all sides, something to which states are no more immune than is Congress or EPA.

The implementing agency, the Department of Toxic Substances Control (DTSC), has provided the following timeframe for implementing the regulations:

  1. Initial Candidate Chemical list → Effective date of the regulations [occurred on October 1, 2013]
  2. First “Proposed” Priority Products list → 180 days after the regulations effective date [released on March 13, 2014]
  3. First Priority Products list finalized → Requires rulemaking (may take up to one year)
  4. Priority Product Notification → 60 days after listing on final Priority Products list
  5. Preliminary AA [Alternatives Assessment] Report → due to DTSC 180 days after listing on final Priority Products list
  6. Final AA Report → due to DTSC 1 year after the notice of compliance for the Preliminary AA Report
  7. Regulatory Response Implementation → To be specified by DTSC in the regulatory response determination

As of this writing – seven years after the California law was passed and 18 months after the regulations were finalized – only the first two steps toward implementation have been taken.  And the initial scope is quite limited:  DTSC’s “draft initial Priority Products list” includes three chemicals, each with respect to a use in one category of products.  DTSC notes that each priority product may entail developing a separate set of regulations.  (The SCP regulations are not a one-shot deal, of course:  The law authorizes DTSC to identify additional priority products containing chemicals of concern going forward.)

The timeframe above makes clear that it will be at least several more years before any regulatory response would be finalized that could potentially restrict the use of one of the three chemicals in its corresponding priority product.

Let me be clear: None of this analysis is to diminish the role states have played and should continue to play in helping to manage chemical safety.  But it is essential to recognize the mismatch between the scale of this problem and the limited ability to address it through a state-by-state strategy.

What about preemption under the Lautenberg Act?

How would preemption under the Lautenberg Act affect all of this activity by states?  (For a full discussion of the preemption provisions in the bill, see my UPDATED post “Understanding Preemption in the Lautenberg Act”).

First, state actions taken before 2015 are grandfathered in regardless of future EPA action.

Second, it is important to remember that the extent of EPA’s activity directly delimits the extent of any preemption of state authority to act on chemicals.  If EPA moves slowly, that means less preemption of state authority, because states are unconstrained in their ability to act until and unless a chemical is taken up by EPA.  Even after EPA does take up a chemical, states can act to address uses or concerns that are not addressed by EPA or fall outside its jurisdiction under TSCA.

Third, as mentioned earlier, many actions taken by states, such as listing chemicals of concern or requiring reporting, monitoring or disclosure of their use, do not impose direct restrictions on production or use, and would not be preempted under the Lautenberg Act.  California’s Proposition 65 warning label requirements is explicitly preserved, including both past and future listings of chemicals subject to its warning and labeling requirements.

How would preemption under the Lautenberg Act affect California’s Safer Products Regulations?  It is only at the final step (#7) in the implementation process outlined above that there is potential for the state’s actions to be preempted under the bill.  And that would occur only if California were to decide to restrict the use of one of the chemicals (as opposed to taking any of the other regulatory responses from which it is to choose at the end of the process), and only then if EPA takes up the same chemical for the same use and to address the same health or environmental concerns.

In an ideal world, we could pass a bill with no preemption, but the whole motivation for pro-business Republicans to come to the negotiating table was to secure a uniform federal program.  Acknowledging the need to find the right balance between federal and state authority in the chemicals space is essential, because – without a balance – there simply won’t be any TSCA reform.

EDF has worked hard to narrow the scope of preemption in this bipartisan legislation, and we remain committed to ensuring the right balance is struck.  But we also recognize that, like it or not, some degree of preemption is the political cost for securing a law that will put us on the path to building a more robust national program that can better protect all Americans.

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One Comment

  1. Posted April 6, 2015 at 5:48 pm | Permalink

    Richard, there's a huge void in your latest uncritical defense of the Senate bill.

    It's that pesky "regulatory void" or "death zone" of inaction that occurs after EPA names a chemical as a high priority. For at least 7 years, the States will be blocked from regulating an unsafe chemical that EPA has not yet acted on. You know what premature preemption means, you just don't want to talk about it. It invites the very same industry delay tactics you've decried in the past. As long as EPA keeps missing its deadlines and is distracted by political tactics and lawsuits, there'll be no action at either the state or federal level on chemicals that everyone agrees are unsafe.

    Then, when EPA finally does take action to restrict a chemical, the State's authority to enforce that same federal rule is taken away under the Vitter-Udall bill. Why? Not to assure compliance, apparently.

    I understand that EDF decided more than two years ago to throw the States under the bus for an illusory promise to review all chemicals for safety (someday). But at least you could be honest about what the States have accomplished. To imply that Mr. Udall's home state of New Mexico has not benefited from state leadership on toxic chemicals is disingenuous at best.

    After Washington state and Maine banned DecaBDE in TVs and computer cases, the manufacturers ceased production and use across the United States. When California ended an unnecessary fire safety standard, furniture makers around the country announced an end to the the use of toxic flame retardants in couches. When Vermont required labeling of mercury in light bulbs, those labels were added to all products nationwide.

    Existing law already strikes a balance between state and federal authority. Under current TSCA, a final EPA action on a chemical preempts a state restriction. Preemption kicks in after, not years before, EPA demonstrates real leadership on dangerous chemicals.

    Supporting radical rollbacks in existing law won't provide our best chance of chemical safety. More like a chimera of safety.